Lead Migration During the Spinal Cord Stimulation Trial Period and Therapeutic Response

Augusta University

Status

Enrolling

Conditions

Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period

Treatments

Procedure: external securement of scs leads during the scs trial period

Study type

Interventional

Funder types

Other

Identifiers

NCT05956548

1994689

Details and patient eligibility

About

The goal of this clinical trial is to compare lead migration distance and therapeutic response for participants receiving a spinal cord stimulator during the trial period. Of note- scs trial period is a procedure name, not to be confused with this clinical trial study.

The main question[s] it aims to answer are:

Is there a difference in migration distance and/or rate for those with external leads secured by an anchor device versus and anchor device with suture?
How does participant activity levels during the trial period compare to migration rates? ° Does the temperature, heat index, and humidity during the trial period impact migration rates? Participants will come in for the scs trial procedure as normal. They will be asked to complete an activity survey upon return to the clinic for lead pull after the scs trial. They will also have an additional image upon return to the clinic to document lead position prior to lead pull.

Researchers will compare two groups- those with securement via anchor and those with securement via anchor and suture to see if there is an impact on therapeutic effect (percentage of pain relief) form the scs trial.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults ages 18 and over without a failed spinal stimulation trial or implant will be accepted into the study. Patients must have a diagnosis of chronic back pain and must be patients of the identified anesthesiologists and have their procedures performed at AUHS pain clinic.

Exclusion criteria

Patients will be excluded if they have a history of local anesthetic allergy (lidocaine), current skin infections at the procedure site, or a diagnosis of diaphoresis/ secondary hyperhidrosis (chronic over sweating).